Your “Rigorously Tested” Claim Is Only as Strong as Your Supplier Spec 

Key takeaways:

• Texas alleges Gerber marketed baby food as “safe” and “rigorously tested” while its lab results revealed elevated arsenic and lead. Gerber disputes the allegations, which haven’t been proven in court.
• The FDA recommended that manufacturers of food for babies and young children control arsenic, cadmium, and lead through their supplier programs, with limits written into specifications and purchase agreements.
• Your supplier specification determines which product claims you can defend and how quickly customers can approve you. Suppliers that provide lot-level heavy metal data have a strong competitive advantage when seeking new business.

Between 2017 and 2019, Gerber’s internal testing identified 67 batches of rice flour containing more than nine times the federal arsenic limit for bottled water. Texas Attorney General Ken Paxton made that allegation when he announced a lawsuit against Gerber Products Co. and Nestlé USA. According to the state, Gerber continued to market its products to parents as safe, pure, and rigorously tested.

The case rests on what the packaging claimed versus what the company’s test records showed. And the supplier specification is what governs that comparison.

Texas based its case on Gerber’s test results

Texas opened its investigation in August 2025, issuing civil investigative demands to Gerber and Plum Organics. The lawsuit, filed under the Texas Deceptive Trade Practices Act (DTPA), adds more details:

• Carrots tested at up to 17 times the bottled-water limit for cadmium, and sweet potatoes at nearly 10 times the limit for lead.
• For most of that period, Gerber tested selected ingredients rather than the finished products infants consumed.
• Testing for mercury was infrequent.
• Gerber now publishes test results through a QR code on its labels, but the metal levels and front-of-pack claims remained unchanged.

According to the attorney general’s office, “a code on the back of the jar does not cure a false promise on the front.”

Gerber said its products meet FDA limits for heavy metals and that it manages them through “careful ingredient sourcing, supplier requirements, testing and quality controls.” Two points may work in the company’s favor. Texas measured results against bottled-water limits rather than a food standard, and the testing it cites predates the FDA’s 2025 lead limits for baby food. The court will consider both.

Plum Organics resolved its portion of the inquiry differently. In September, the company reached an agreement with Texas under which it will follow FDA guidance on lead, adopt EU limits for cadmium and inorganic arsenic, and maintain a 10 parts per billion (ppb) internal limit for mercury in pouches. Plum will also publish results that parents can search by UPC or lot number and will not ship product that fails to meet these standards.

The FDA now expects heavy metal limits in supplier programs

Days after Texas filed suit, the FDA released Chapter 12 of its draft preventive controls guidance, which addresses chemical hazards. For food intended for babies and young children, the agency recommends treating applicable toxic elements as “hazards requiring a supply-chain program as a preventive control.”

For toxic elements, the recommended control is “setting specifications in supplier programs and purchase agreements.” The agency also notes that a recommended contaminant level can serve “as a factor in developing a specification.”

So, following this guidance, a manufacturer should include arsenic, cadmium, and lead limits in its purchase agreements, while suppliers maintain a periodic testing program and submit results annually. The manufacturer reviews supplier data before accepting a first shipment and tests finished product quarterly to confirm the program remains effective.

The FDA’s final lead guidance, issued in January 2025, set action levels of 10 ppb for most processed baby foods and 20 ppb for single-ingredient root vegetables and dry infant cereals. On the same day it released Chapter 12, the agency proposed cadmium action levels:

• 10 ppb for fruits, vegetables other than single-ingredient carrots, and mixtures
• 20 ppb for yogurts, puddings, and custards
• 25 ppb for single-ingredient carrots and single-ingredient meats
• 45 ppb for dry infant cereals

The FDA’s data indicates where compliance will be most challenging. Only 84% of single-ingredient carrot samples fell at or below the proposed 25 ppb level, meaning roughly one in six would exceed it. Comments are due Jan. 21, 2027, and the FDA’s Closer to Zero page lists draft arsenic levels as a 2027 target.

These action levels are nonbinding guidance and apply to processed food for children under 2. The supplier verification requirements that support them apply far more broadly. Under 21 CFR 117.410, verification activities can include onsite audits, sampling and testing, and review of a supplier’s food safety records.

Your specification determines which claims you can defend

In litigation, opposing counsel will ask the same questions a well-written specification should answer: 

• Which metals are covered? 
• What are the limits? 
• Are results measured on the ingredient lot, the finished product, or both? 
• Who performs the testing, and how often? 
• What happened when a result exceeded the limit, and who approved the decision?

If a specification doesn’t address cadmium, a “tested” claim covers less than consumers are likely to assume. Meeting an FDA action level may not resolve the question either. In September, Consumer Reports found that Gerber Rice Cereal averaged 63 ppb inorganic arsenic, below the FDA’s action level for infant rice cereal but above CR’s own level of concern.

The same statute extends well beyond baby food. Texas has also opened a DTPA investigation into “made with avocado oil” claims by Primal Kitchen, Siete Foods, and Chosen Foods. Every claim about purity, testing, or ingredients ultimately depends on documentation maintained by your quality team.

Six provisions to add to your supplier specification this quarter

Begin with the ingredients that carry the greatest risk for your product categories. Lead is a potential hazard in carrots and sweet potatoes, and rice flour is central to the Texas complaint.

1. Identify the metals for each ingredient. List arsenic, cadmium, and lead by name wherever they are reasonably foreseeable. A general statement that an ingredient “meets all applicable regulations” offers little support if your claims are challenged.
2. Set a numeric limit for each, with documented rationale. Use FDA action levels as a reference point. For infant or toddler products, consider internal limits below those levels to account for lab variability and for processing steps that concentrate solids.
3. Define the testing protocol. Specify the accredited laboratory, test method, detection limit, and frequency. Link every result to a lot code to preserve traceability.
4. Include finished product testing. Part of the Texas complaint focuses on ingredient-only testing. Pair supplier data with quarterly finished product checks.
5. Document the exceedance procedure. Define the steps for hold, retest, rejection, and notification, assign an owner to each, and record every decision.
6. Align marketing claims with test data. Before packaging or marketing materials use terms such as “tested,” “pure,” or “safe,” require quality assurance to confirm that the specification and results support them.

Documented metals data makes suppliers easier to approve

For suppliers of rice flour, vegetable purees, or other ingredients used in children’s food, the FDA’s guidance directs customers to write metals limits into their purchase agreements. Suppliers should anticipate more detailed questionnaires. A supplier that can provide 12 months of lot-level results is easier to approve.

Brand owners are already differentiating on documentation. Consumer Reports found that 96% of the 48 baby foods it tested fell below its heavy metal levels of concern. As low levels become the norm, the brands that stand out are those that can substantiate their results publicly. Consumer Reports noted that Little Spoon screens for more than 500 toxins and publishes results through a transparency hub, and Plum’s agreement with Texas commits it to lot-searchable public results.

A well-defined specification also supports growth. A new retail account, a private label bid, or a toddler line extension typically comes with its own documentation requirements. When limits, testing protocols, and data are already in place, those requests can be fulfilled quickly rather than becoming a project.

The Texas case will likely take months to resolve, and the comment period for the FDA’s cadmium guidance is open through January. In the meantime, review the specifications for your five highest-risk ingredients and confirm that arsenic, cadmium, and lead each have a defined numeric limit.